Inotek Pharmaceuticals Announces the Completion of the Recruitment Phase of MATrX-1, the First Phase 3 Clinical Trial of Trabodenoson for Glaucoma

LEXINGTON, Mass.--(BUSINESS WIRE)--Inotek
Pharmaceuticals Corporation (NASDAQ: ITEK), a clinical-stage
biopharmaceutical company focused on the discovery, development and
commercialization of therapies for ocular diseases, today announced the
completion of the active recruitment phase of MATrX-1, the first pivotal
Phase 3 trial of trabodenoson for the treatment of glaucoma. Trabodenoson,
the Company’s lead clinical candidate, is a first-in-class selective
adenosine A1 mimetic under investigation for reduction of
intraocular pressure (IOP) which has been observed in Phase 2 clinical
trials to reduce IOP. Top-line data from the MATrX-1 study are expected
in December 2016.

“As anticipated, MATrX-1 has recruited on time, consistent with our
fourth-quarter guidance for top-line data,” said Rudolf Baumgartner, MD,
Executive Vice President and Chief Medical Officer. “Trabodenoson
has the potential to be a convenient, safe and innovative treatment
option for patients suffering from glaucoma based on its targeted
approach of restoring the natural pressure-regulating process in the eye
to lower IOP, and we are looking forward to the results of this trial.”

About the MATrX-1 Phase 3 TrialMATrX-1 is a Phase 3
randomized, double-masked, placebo-controlled trial of trabodenoson
in (~)335 patients suffering from primary open angle glaucoma (POAG) or
ocular hypertension (OHT) that is designed to assess the efficacy,
safety and tolerability of trabodenoson over three months of
treatment. The primary endpoint is reduction of IOP as compared to the
placebo treatment arm. The study includes three doses of trabodenoson:
3% (1000 mcg) once daily, 4.5% (1500 mcg) twice daily, and 6% (2000 mcg)
once daily. In addition, the study contains a timolol 0.5% arm to
validate the sensitivity of the patient population and will serve as an
internal control. Enrollment criteria include patients with IOP greater
than or equal to 24 mm Hg and less than or equal to 34 mm Hg, which
represents the patients most likely to receive treatment for glaucoma or
ocular hypertension.

About Inotek Pharmaceuticals CorporationInotek
Pharmaceuticals is a clinical-stage biopharmaceutical company focused on
the discovery, development and commercialization of therapies for
glaucoma and other eye diseases. The Company’s lead product candidate, trabodenoson,
is a first-in-class selective adenosine mimetic currently in Phase 3
development. Trabodenoson was developed in Inotek’s
laboratories and is designed to restore the eye’s natural pressure
control mechanism. Additionally, the Company is evaluating the potential
for selective adenosine mimetics to address optic neuropathies and other
degenerative retinal diseases. For more information, please visit www.inotekpharma.com.
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